VK2735's manufacturing alliance with CordenPharma

Viking secures a manufacturing alliance with CordenPharma, promising "metric tons" of production of VK2735

VK2735's manufacturing alliance with CordenPharma

We've briefly covered Viking Therapeutic's VK2735 in the past:

Viking Therapeutic’s new GLP1 produces oustanding results
At ObesityWeek 2024, Viking Therapeutic showed study results on their new drug VK2735 -- 8% body weight loss at 28 days, in the highest dose.

It's produced great results in the past, and recently some more exciting announcements have been made: Viking is partnering with CordenPharma to ensure manufacturing capability for their VK2735 GLP1-agonist.

According to the press release, "multiple metric tons" of VK2735:

Under the terms of the agreement, Viking has secured dedicated capacity for the manufacture of, and a commitment to supply annually, multiple metric tons of VK2735 API. 

In addition, CordenPharma will provide fill/finish capacity for both the injectable and oral formulations of VK2735.

This includes dedicated manufacturing lines and an annual commitment to supply 100 million autoinjectors and an additional 100 million vial and syringe products for the subcutaneous formulation, as well as an annual capacity of over one billion oral VK2735 tablets. These API and final finished product capacities are further expandable at Viking's option.
Viking Therapeutics Signs Broad Manufacturing Agreement With CordenPharma to Support Commercialization of VK2735
Long-Term Agreement Secures Dedicated Capacity for Multi-Ton Annual Supply of VK2735 Active Pharmaceutical Ingredient Secures Dedicated Fill/Finish Capacity for 100 Million Annual Autoinjector…

Who is CordenPharma?

CordenPharma is a contract development and manufacturing organization ("CDMO") which also had a part in manufacturing the COVID19 vaccines.

While CordenPharma hasn't made many outwardly notable waves in the GLP1 space as of recent, this partnership with Viking makes it clear the difficulty of finding partners to produce GLP1 agonists, and securing that capacity.

Catalent's purchase by Novo Nordisk in 2024 was one of the key indicators that it was getting more difficult to find capacity to produce the GLP1 injection pens that everyone has come to know:

Shortage ends for Eli Lilly (Mounjaro, Zepbound)
Bad news that sounds like good news: FDA ends shortage Eli Lilly’s GLP-1 (Tirzepatide). We’ll tell you why that’s bad news.

What is VK2735?

VK2735 is a GLP1 Receptor Agonist developed by Viking Pharmaceuticals that is so early it doesn't have a proper name yet – it's a dual agonist of the GIP and GLP1 receptors – similar to Tirzepatide.

VK2735 - Wikipedia

Reports from trials were successful early in 2024:

Viking Therapeutics Announces Positive Top-Line Results from Phase 2 VENTURE Trial of Dual GLP-1/GIP Receptor Agonist VK2735 in Patients with Obesity
Study Achieves Primary and all Secondary Endpoints, Demonstrating Statistically Significant Reductions in Body Weight at all Doses as Compared to Placebo Up to 13.1% Placebo-Adjusted Mean Weight…

And later in the year after reporting an update to trial data at Obesity Week 2024, the results continued to impress:

Viking Therapeutics Reports New Data from VK2735 Obesity Program at ObesityWeek® 2024
Up to 6.8% Placebo-Adjusted Mean Weight Loss (8.2% from Baseline) After 28 Days of Dosing with Oral Tablet of VK2735 Encouraging Tolerability Through 100 mg Daily Dosing with Oral VK2735; Mild…

The key worry noted (which caused turbulence in Viking Therapeutic's stock) was that Viking may not be able to secure manufacturing for VK2735:

Viking Therapeutics’ Hot Stock Slips After Latest Obesity Drug Trial Results
Viking Therapeutics shares rose Monday morning before reversing course and declining after reporting the latest results from clinical trials of its weight loss drugs.

Those concerns seem to now be put to rest, at least partially.

What will this do for GLP1 supply?

While the dual shocks of Tirzepatide and Semaglutide coming off the shortage list are still looming and going to be a disruption to supply of GLP1s and compounded GLP1 in the short term, VK2735 securing a route to mass production is a step in the right direction.

While VK2735 has not been approved by the FDA yet, and it has not actually started being produced for mass consumption, assuming it can clear those hurdles there is now reserved capacity that will ensure they can enter the market and produce their drug.

In the long term, VK2735, along with patent expirations in other GLP1s and current supply should boost the amount of GLP1 that is available to those who want it.

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